AlcoholismNCT00300638
Alcoholism: Emotion and Thinking
An observational study of Alcoholism, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether long-term chronic alcoholism is associated with changes in emotional functioning and brain structure and function. Read more about this study
- Who is it for?
- Ages 25 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Interviews, cognitive tests, and emotional measurements
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 599 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to 21 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Alcoholics and demographically equivalent healthy controls who have participated in one or more of our prior studies are contacted by telephone to determine whether or not they would like to participate again. Potential participants who have not previously been enlisted in any of our studies are recruited through fliers placed in the Boston Veterans Affairs Healthcare System, BU School of Medicine, and after-care programs in the Boston area, and through ads in local newspapers and web sites. For "new" participants, subject selection procedures include an initial prescreening telephone interview to determine identifying information such as age, level of education, health history, and history of alcohol and drug use and if eligible are invited to the laboratory for further screening and neuropsychological evaluations.
Who may be able to join
- Male and female right-handed people 25 years of age or older.
- Participants either will have a past Diagnostic and Statistical Manual version IV (DSM-IV) diagnosis of alcohol dependence, or no such history at all.
- Participants will have signed an informed consent.
Who cannot join
- Pregnant women.
- Shrapnel or other metal in body (dental fillings OK)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Hospital and Massachusetts General Hospital
Boston, Massachusetts, 02130
About this study
Official title: Affective and Conative Changes in Alcoholism
The purpose of this study is to determine whether long-term chronic alcoholism is associated with changes in emotional functioning and brain structure and function.
Read the detailed description
This research investigates brain structure and function in alcoholics compared to healthy nonalcoholic individuals. Alcoholics have shown impairments in cognitive processing of emotional signals. Some alcoholics are impaired in social skills, and many are unable to implement the strategies for interpersonal interactions that they recommend for themselves. For example, alcoholics have difficulty interpreting non-verbal emotional cues and recognizing facial expressions of emotion. When listening to sentences, alcoholics also have some difficulty judging emotional intonations and emotional content. In our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
- Conditions
- Alcoholism
- Being tested
- Magnetic Resonance Imaging (MRI), Interviews, cognitive tests, and emotional measurements
- Keywords
- Alcoholism, Emotion, Cognition, Brain scans
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
Interviews, cognitive tests, and emotional measurementsBehavioural
We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
| Study group | Role | What they receive |
|---|---|---|
| 1- MRI and interviews | In our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using Magnetic Resonance Imaging (MRI) scans, we observe how the brain works when people purposefully respond to the words and pictures. Interviews, cognitive tests, and emotional measurements will also be done. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli. Receives: Procedure: Magnetic Resonance Imaging (MRI); Behavioral: Interviews, cognitive tests, and emotional measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcoholism's effects on thinking, behavior and brain functioning
Measured: several visits over approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startAug 2001
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Why it stopped: The study was terminated prematurely because of restrictions imposed by COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Marlene O. Berman, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300638
- Sponsor's protocol ID
- H-24686
- Other IDs
- R01AA007112, K05AA000219
- Status last verified
- Jul 2021
- First submitted
- 7 Mar 2006
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oscar-Berman M, Marinkovic K. Alcoholism and the brain: an overview. Alcohol Res Health. 2003;27(2):125-33.
PubMed 15303622
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective and Conative Changes in Alcoholism
- ClinicalTrials.gov ID
- NCT00300638
- Acronym / sponsor ID
- H-24686
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Emotion, Cognition, Brain scans
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because of restrictions imposed by COVID-19.
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), US Department of Veterans Affairs
- Study start
- Aug 2001 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether long-term chronic alcoholism is associated with changes in emotional functioning and brain structure and function.
Detailed description
This research investigates brain structure and function in alcoholics compared to healthy nonalcoholic individuals. Alcoholics have shown impairments in cognitive processing of emotional signals. Some alcoholics are impaired in social skills, and many are unable to implement the strategies for interpersonal interactions that they recommend for themselves. For example, alcoholics have difficulty interpreting non-verbal emotional cues and recognizing facial expressions of emotion. When listening to sentences, alcoholics also have some difficulty judging emotional intonations and emotional content. In our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1- MRI and interviews | – | Procedure: Magnetic Resonance Imaging (MRI), Behavioral: Interviews, cognitive tests, and emotional measurementsIn our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using Magnetic Resonance Imaging (MRI) scans, we observe how the brain works when people purposefully respond to the words and pictures. Interviews, cognitive tests, and emotional measurements will also be done. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli. |
Who may qualify
- Ages
- 25 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Alcoholics and demographically equivalent healthy controls who have participated in one or more of our prior studies are contacted by telephone to determine whether or not they would like to participate again. Potential participants who have not previously been enlisted in any of our studies are recruited through fliers placed in the Boston Veterans Affairs Healthcare System, BU School of Medicine, and after-care programs in the Boston area, and through ads in local newspapers and web sites. For "new" participants, subject selection procedures include an initial prescreening telephone interview to determine identifying information such as age, level of education, health history, and history of alcohol and drug use and if eligible are invited to the laboratory for further screening and neuropsychological evaluations.
Key inclusion criteria (3 listed)
- Male and female right-handed people 25 years of age or older.
- Participants either will have a past Diagnostic and Statistical Manual version IV (DSM-IV) diagnosis of alcohol dependence, or no such history at all.
- Participants will have signed an informed consent.
Key exclusion criteria (2 listed)
- Pregnant women.
- Shrapnel or other metal in body (dental fillings OK)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli. | Procedure or surgery | 1- MRI and interviews |
| Interviews, cognitive tests, and emotional measurementsWe present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli. | Behavioural | 1- MRI and interviews |
Primary outcome
Alcoholism's effects on thinking, behavior and brain functioning
Time frame: several visits over approximately one month
Results and safety
The study was stopped early (reason given: The study was terminated prematurely because of restrictions imposed by COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 15303622Oscar-Berman M, Marinkovic K. Alcoholism and the brain: an overview. Alcohol Res Health. 2003;27(2):125-33.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene O. Berman, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely because of restrictions imposed by COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcoholism's effects on thinking, behavior and brain functioning (time frame: several visits over approximately one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.